| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K962467 |
06/25/1996 |
RV PACING LEAD |
ABBOTT LABORATORIES |
DAVE GUZEK |
| K962419 |
06/24/1996 |
CW-DISPOSABLE ACUPUNCTURE NEEDLE |
ACUPUNCTURE SUPPLIES IMPORT CO. |
LYNN H HSU |
| K962698 |
06/17/1996 |
ACUTEK'S CLEARPASAGE |
ACUTEK ADHESIVE SPECIALTIES, INC. |
MARCIA FAJARDO |
| K962495 |
06/26/1996 |
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115" ROTATING HEMOSTATIC VALVE) |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
MARGARET ANDERSON |
| K962493 |
06/26/1996 |
ENDOSCOPIC CLIP APPLIER |
AESCULAP, INC. |
MARY ELLEN HOLDEN |
| K962402 |
06/21/1996 |
AMO PRESTIGE DAY PACK (ALLERGAN, INC.) |
ALLERGAN, INC. |
MONIQUE M HEYNINCK |
| K962309 |
06/17/1996 |
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
MARY LANE |
| K962469 |
06/25/1996 |
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K962330 |
06/17/1996 |
AMO ARTHOSCOPES |
AMERICAN MICROPTIKS, INC. |
GEORGE HALLACK |
| K962539 |
06/28/1996 |
GANTEX MODEL NSG-75PF |
AMERICAN PRO LATEX, INC. |
ROSS LITTON |
| K962400 |
06/21/1996 |
AIR MAX EXTERNAL NASAL DILATOR STRIP |
AMERICAN WHITE CROSS, INC. |
PAUL B CALLAHAN |
| K962424 |
06/24/1996 |
NPB-4000 |
ANALOGIC CORP. |
JAMES R LEVANI |
| K962395 |
06/20/1996 |
SPECIMEN RETRIEVAL BAG |
APPLIED MEDICAL RESOURCES |
HOWARD V ROWE |
| K962183 |
06/06/1996 |
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER "FIRST RESPONSE", ANSWER", OR OTHER BRAND NAMES |
ARMKEL, LLC. |
MAUREEN GARNER |
| K962321 |
06/17/1996 |
ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970 |
ARTHROCARE CORP. |
CHERYL L SHEA |
| K962445 |
06/24/1996 |
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM |
ARTHROCARE CORP. |
CHERYL L SHEA |
| K962268 |
06/13/1996 |
CHROME COBALT BALL HEAD |
ARTOS MEDICAL PRODUCTS GMBH |
DOUGLAS W STUART |
| K962230 |
06/10/1996 |
CELSITE PORT WITH PRECONNECTED CATHETER |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K962141 |
06/03/1996 |
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K962499 |
06/26/1996 |
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER |
BARTELS, INC. |
REBECCA D FULLER |
| K962161 |
06/04/1996 |
BAXTER NEBULIZER CAP MODEL 2D0868 |
BAXTER HEALTHCARE CORP. |
ED RANSOM |
| K962355 |
06/18/1996 |
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K962344 |
06/18/1996 |
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K962125 |
06/03/1996 |
TECHNICON IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K962156 |
06/04/1996 |
3304 PULSE OXIMETER |
BCI INTL., INC. |
DONALD J ALEXANDER |
| K962294 |
06/14/1996 |
IMMAGE IMMUNOCHEMISTRY SYSTEM |
BECKMAN INSTRUMENTS, INC. |
SHERI HALL |
| K962210 |
06/10/1996 |
BACTEC 9050 SYSTEM |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
ROBERT E JAMES |
| K962423 |
06/24/1996 |
BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
VIRGINIA C WEINKNECHT |
| K962519 |
06/27/1996 |
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS |
BEHRING DIAGNOSTICS, INC. |
PAUL L ROGERS |
| K962406 |
06/21/1996 |
N CRP STANDARD SY |
BEHRING DIAGNOSTICS, INC. |
KATHLEEN DRAY-LYONS |
| K962410 |
06/21/1996 |
N PROTEIN STANDARD PY |
BEHRING DIAGNOSTICS, INC. |
KATHLEEN DRAY-LYONS |
| K962407 |
06/21/1996 |
N/T PROTEIN CONTROL PY |
BEHRING DIAGNOSTICS, INC. |
KATHLEEN DRAY-LYONS |
| K962373 |
06/20/1996 |
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 |
BEHRING DIAGNOSTICS, INC. |
KATHLEEN DRAY-LYONS |
| K962286 |
06/14/1996 |
2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD |
BERKLEY MEDICAL RESOURCES, INC. |
PAUL ZELLNER |
| K962275 |
06/13/1996 |
MAICO MA25 SERIES II WITH SPEECH |
BERNAFON-MAICO, INC. |
SCOTT SAVRE |
| K962266 |
06/12/1996 |
0.014 INCH EXTRA LONG FLOPPY AND 0.014" EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING |
BIOCOMPATIBLES CARDIOVASCULAR, INC. |
NANCY F TEAGUE |
| K962317 |
06/17/1996 |
MAGNES 2500 WH BIOMAGNETOMETER |
BIOMAGNETIC TECHNOLOGIES, INC. |
EUGENE C HIRSCHKOFF, PH.D. |
| K962216 |
06/10/1996 |
TSH (MICROWELL) ELISA |
BIOMERICA, INC. |
JAY SINGH |
| K962549 |
06/28/1996 |
VIDAS CREATINE KINASE MB ASSAY 30-421 |
BIOMERIEUX VITEK, INC. |
TERRY MCGOVERN |
| K962300 |
06/13/1996 |
CLAMPLESS VALVED CATHETER |
BMW MEDICAL, INC. |
PHIL TRIOLO, PH.D. |
| K962269 |
06/13/1996 |
CEDIA CARDIAC TDM MULTI-CALS |
BOEHRINGER MANNHEIM CORP. |
MARY KONING |
| K962508 |
06/27/1996 |
ELECSYS T3 |
BOEHRINGER MANNHEIM CORP. |
LEEANN CHAMBERS |
| K962240 |
06/11/1996 |
MOORE TRACHEOSTOMY TUBE |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
| K962375 |
06/20/1996 |
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K962538 |
06/28/1996 |
BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) |
C.R. BARD, INC. |
EVANS YI-WEN WUU |
| K962177 |
06/06/1996 |
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT |
C.R. BARD, INC. |
SANDRA L PERREAND |
| K962178 |
06/06/1996 |
BARD TIGER GUIDEWIRE MODEL 000540 |
C.R. BARD, INC. |
BETH A ROCHETTE |
| K962458 |
06/25/1996 |
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER |
CADWELL LABORATORIES, INC. |
LEONARD RUFF |
| K962455 |
06/25/1996 |
FOUR-CHANNEL PREAMPLIFIER |
CADWELL LABORATORIES, INC. |
CARLTON M CADWELL |
| K962457 |
06/25/1996 |
TWO-CHANNEL PREAMPLIFIER |
CADWELL LABORATORIES, INC. |
LEONARD RUFF |
| K962154 |
06/04/1996 |
CARBOMEDICS HANDLE |
CARBOMEDICS, INC. |
JOY FISHER-SHUGART |
| K962218 |
06/10/1996 |
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG |
CARRINGTON LABORATORIES, INC. |
DENNIS R SPARKMAN, PH.D. |
| K962250 |
06/12/1996 |
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED |
CARROLL HEALTHCARE, INC. |
NORM KAY |
| K962370 |
06/19/1996 |
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE |
CHALLENGE PRODUCTS, INC. |
RICHARD O WOOD |
| K962426 |
06/24/1996 |
CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 |
CHRONO-LOG CORP. |
NICHOLAS J VERIABO |
| K962436 |
06/24/1996 |
SUNGLASSES |
CHUNGSIN KAU OPTICAL MFY. CO. LTD. |
HOU KAU CHAN |
| K962126 |
06/03/1996 |
ACS CKMB II IMMUNOASSAY |
CIBA CORNING DIAGNOSTICS CORP. |
THOMAS F FLYNN |
| K962431 |
06/24/1996 |
CTM DISPOSABLE PAK |
CIRCUIT TREE MEDICAL, INC. |
GLENN A DUNKI-JACOBS |
| K962430 |
06/24/1996 |
CTM REUSABLE PAK |
CIRCUIT TREE MEDICAL, INC. |
GLENN A DUNKI-JACOBS |
| K962255 |
06/12/1996 |
CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) |
CLARUS MEDICAL SYSTEMS, INC. |
JOHN VANDEN HOEK |
| K962310 |
06/17/1996 |
NON-GENERIC |
CLASSIC ELEGANCE INTL., INC. |
FOOK LOY SOTHAM |
| K962432 |
06/24/1996 |
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL |
CLINICAL CONTROLS, INC. |
JAMES F GODFREY |
| K962242 |
06/11/1996 |
SURESCAN |
CLINICON CORP. |
ALAN BUNTING |
| K962364 |
06/19/1996 |
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) |
CODONICS, INC. |
PETER BOTTEN |
| K962140 |
06/03/1996 |
ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300 |
CONTINENTAL X-RAY CORP. |
OSCAR KHUTORYANSKY |
| K962167 |
06/05/1996 |
BRONCHIAL BLOCKER |
COOK, INC. |
APRIL LAVENDER |
| K962185 |
06/06/1996 |
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS |
COOPERVISION, INC. |
BERNARD HALLATT |
| K962362 |
06/19/1996 |
CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS |
CORDIS CORP. |
KATHERINE TREVISOL |
| K962768 |
06/17/1996 |
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL |
COULTER CORP. |
MARION S GAIDE |
| K962305 |
06/17/1996 |
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL |
COULTER CORP. |
MARION S GAIDE |
| K962478 |
06/25/1996 |
(BRAND NAME) SUNGLASS FRAMES |
CUSTOM OPTICAL FRAMES, INC. |
MARC H AST |
| K962150 |
06/04/1996 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE INTL., INC. |
SHARON CULLEN |
| K962473 |
06/25/1996 |
(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH |
DATA CRITICAL CORPORATION |
RAY PIZINGER |
| K962290 |
06/14/1996 |
DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER |
DEBUSK TECHNOLOGY CORP. |
CAMILLE MATLOCK |
| K962277 |
06/13/1996 |
SELF CURE BONDING AGENT |
DENT ZAR, INC. |
EUGENE ZAROTSKY |
| K962348 |
06/18/1996 |
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K962486 |
06/26/1996 |
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM |
DEPUY, INC. |
CHERYL HASTINGS |
| K962306 |
06/17/1996 |
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES |
DIAGNOSTIC HYBRIDS, INC. |
JAMES L BROWN |
| K962311 |
06/17/1996 |
FRESHFROZENCELLS |
DIAGNOSTIC HYBRIDS, INC. |
J.L. BROWN |
| K962323 |
06/17/1996 |
IMMULITE OPIATES SCREEN/CONTROL MODULE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K962463 |
06/25/1996 |
PROCAINAMIDE ENZYME IMMUNOASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY,PH.D. |
| K962260 |
06/12/1996 |
REAL-TIME VIDEO CONTRAST ENHANCER |
DIGIVISION, INC. |
CHARLES A BRASS |
| K962521 |
06/19/1996 |
FACTPLUS ONE STEP PREGNANCY TEST |
DIRECT ACCESS DIAGNOSTICS |
MARYLOU PANICO |
| K962371 |
06/19/1996 |
DERMTOME BLADE |
DSP WORLDWIDE |
ROSINA ROBINSON |
| K962544 |
06/28/1996 |
MICRO DIAMOND-POINT DISSECTION NEEDLES |
DSP WORLDWIDE |
ROSINA ROBINSON |
| K962365 |
06/19/1996 |
XENON LIGHTSOURCE |
DSP WORLDWIDE |
ROSINA ROBINSON |
| K962135 |
06/03/1996 |
D.O.R.C. MICRODIATHERMY SYSTEM |
DUTCH OPHTHALMIC USA, INC. |
MARK W FURLONG |
| K962181 |
06/06/1996 |
HARE MODEL 2000 EZ LOADER MODEL 95555 |
DYNA CORP. |
HENRY C PERRY |
| K962265 |
06/12/1996 |
MLX MICROTITER PLATE LUMINOMETER |
DYNATECH LABORATORIES, INC. |
LARRY POOL |
| K962405 |
06/21/1996 |
SANICURE DISPOSABLE CURING PROBE |
EFOS CANADA, INC. |
EDWARD SMITH |
| K962243 |
06/11/1996 |
VASOTHERM |
EHTI MEDICAL CORP. |
JAMES B BINGHAM |
| K962247 |
06/11/1996 |
HICHEM CK/NAC REAGENT KIT |
ELAN PHARMA, INC. |
WYNN STOCKING |
| K962292 |
06/14/1996 |
HEARSAVER |
EMTECH LABORATORIES |
LOUISE H VERMILLIAN |
| K962293 |
06/14/1996 |
ENDOSONICS AUTOMATIC PULL BACK DEVICE |
ENDOSONICS CORP. |
ADAM D SAVAKUS |
| K962428 |
06/24/1996 |
EBS (ESPE BONDING SYSTEM) |
ESPE GMBH & CO. KG. |
BARBARA WAGNER |
| K962442 |
06/24/1996 |
HYTAC APLITIP/HYTAC OSB |
ESPE GMBH & CO. KG. |
BARBARA WAGNER |
| K962440 |
06/24/1996 |
PERTAC II/PERTAC II APLITIP |
ESPE GMBH & CO. KG. |
BARBARA WAGNER |
| K962548 |
06/28/1996 |
BSM BONE SUBSTITUTE MATERIAL KIT |
ETEX CORP. |
DOSUK D LEE |
| K962258 |
06/12/1996 |
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP |
ETHICON ENDO-SURGERY, INC. |
MELISSA WALKER, M.S., R.A.C. |
| K962480 |
06/26/1996 |
COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED |
ETHICON, INC. |
JOHN D PAULSON |
| K962530 |
06/28/1996 |
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH |
ETHICON, INC. |
JOHN D PAULSON, PH.D. |
| K962146 |
06/03/1996 |
EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT |
EXCEL SCIENTIFIC, INC. |
MIN-LEE CHENG |
| K962532 |
06/28/1996 |
RODENSTOCK SLITLAMP (MODEL 5000 & 4000) |
EXPERTECH ASSOC., INC. |
DAVID M LINK |
| K962497 |
06/26/1996 |
Q-TIPS, FAICHNEY, PRIVATE LABEL |
FAICHNEY MEDICAL CO. |
M. JAMES DAVIS |
| K962159 |
06/04/1996 |
STERILE AMBULATORY RESERVOIR 60ML/100ML |
FAULDING MEDICAL DEVICE CO. |
BRUCE CRANEY |
| K962312 |
06/17/1996 |
KEY CHAIN EMERGENCY AIRWAY |
FFRENCH POCKET EMERGENCY AIRWAY, INC. |
H. CLAY WILSON, P.E. |
| K962307 |
06/17/1996 |
RHYDER DIAGNOSTIC CATHETER |
FIDUS MEDICAL TECHNOLOGY CORP. |
TED ORMSBY |
| K962256 |
06/12/1996 |
GALILEO HYSTEROSCOPES AND LAPAROSCOPES |
GALILEO ELECTRO-OPTICS CORP. |
MARY MCNAMARA-CULLINANE |
| K962427 |
06/24/1996 |
COBE CENTRYSYSTEM 700 HG HEMODIALYZER |
GAMBRO HEALTHCARE |
JEFFREY R SHIDEMAN, PH.D. |
| K962711 |
06/10/1996 |
GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS |
GELFLEX LABORATORIES |
PETER G BRYANT |
| K962710 |
06/10/1996 |
GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS |
GELFLEX LABORATORIES |
PETER G BRYANT |
| K962217 |
06/10/1996 |
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT |
GEN-PROBE, INC. |
GERALD H SCHELL |
| K962249 |
06/11/1996 |
PIXELL MRI SYSTEM |
GENERAL MEDICAL EQUIPMENT CORP. |
RICHARD C LANZILLOTTO |
| K962186 |
06/06/1996 |
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR |
GENZYME CORP. |
NANCY E ISAAC |
| K962329 |
06/17/1996 |
GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 |
GLOBAL MEDICAL PRODS, INC. |
PETER CLARK |
| K962343 |
06/18/1996 |
TOXO IGG ELISA TEST |
GULL LABORATORIES, INC. |
FRED W RACHFORD, PH.D. |
| K962506 |
06/27/1996 |
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] |
GYNECARE INNOVATION CENTER |
MICHAEL A DANIEL |
| K962482 |
06/26/1996 |
SCUBA SYSTEM |
GYNECARE, INC. |
MILTON B MCCOLL, M.D. |
| K962829 |
06/28/1996 |
HARMAC BALLOON ANGIOGRAPHIC CATHETER |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH M KNOIECZNY |
| K963335 |
06/28/1996 |
HARMAC BALLOON WEDGE PRESSURE CATHETER |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH KONIECZNY |
| K963073 |
06/28/1996 |
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH M KONIECZNY |
| K963074 |
06/28/1996 |
HARMAC QUADPOLAR MAPPING PACING CATHETER |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH M KONIECZNY |
| K962833 |
06/28/1996 |
HARMAC TEMPORARY PACING CATHETER WITH BALLOON |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH M KONIECZNY |
| K963336 |
06/28/1996 |
HARMAC THERMODILUTION CATHETER |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH KONIECZNY |
| K962246 |
06/11/1996 |
RIGID FIBER OPTIC LAPAROSCOPE |
HEALTH CARE INTERNATIONAL ASSOC. |
RONALD J EHMSEN |
| K962517 |
06/27/1996 |
MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV |
HEALTHDYNE TECHNOLOGIES, INC. |
TIMOTHY Y COWART |
| K962366 |
06/19/1996 |
HEARTPORT CABLE BULLDOG CLAMP |
HEARTPORT, INC. |
ISABELLA R ABATI, M.S. |
| K962510 |
06/27/1996 |
HEARTPORT ENDOAORTIC CLAMP |
HEARTPORT, INC. |
ROBERT J CHIN |
| K962276 |
06/13/1996 |
HEMAGEN ENA DSDNA KIT (EIA METHOD) |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K962128 |
06/03/1996 |
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) |
HEMO SAPIENS, INC. |
B. BO SRAMEK |
| K962415 |
06/12/1996 |
HEMOCUE B-GLCOSE SYSTEM |
HEMOCUE, INC. |
CLAS RUNNBERG |
| K962308 |
06/17/1996 |
EUB-905 |
HITACHI MEDICAL CORP. OF AMERICA |
CHARLES F HOTTINGER, PH.D. |
| K962537 |
06/28/1996 |
INCARE HOT/ICE LITE MACHINE |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K962234 |
06/11/1996 |
STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416) |
HOWARD MEDICAL CO. |
ROSS LITTON |
| K962162 |
06/04/1996 |
DALL-MILES TROCHANTER CABLE SUPERGRIP |
HOWMEDICA CORP. |
FRANK MAAS |
| K962450 |
06/18/1996 |
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM |
| K962452 |
06/18/1996 |
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM |
| K962341 |
06/18/1996 |
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM |
| K962451 |
06/18/1996 |
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) |
HYCOR BIOMEDICAL, INC. |
MEHDI ALEM |
| K962166 |
06/04/1996 |
ORIGEN ANALYZER |
IGEN, INC. |
RICHARD PYTELEWSKI |
| K962335 |
06/17/1996 |
MLC FIT |
IMPAC MEDICAL SYSTEMS, INC. |
JOSEPH K JACHINOWSKI |
| K962465 |
06/25/1996 |
TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
| K962394 |
06/20/1996 |
IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS |
IMPLANT INTEGRATION SYSTEMS, INC. |
CORY D HANOSH |
| K962261 |
06/12/1996 |
IMPLANTECH WM NASAL-LABIAL IMPLANT |
IMPLANTECH ASSOCIATES, INC. |
EDWARD M BASILE |
| K962468 |
06/25/1996 |
HEDROCEL ACETABULAR RESTRICTOR |
IMPLEX CORP. |
GARY J SFEIR |
| K962422 |
06/24/1996 |
INFIMED DENTAL SYSTEM |
INFIMED, INC. |
MORTEZA MINAEE |
| K962372 |
06/19/1996 |
UROTAC BONE ANCHOR INSERTER |
INFLUENCE, INC. |
PETER A BICK |
| K962421 |
06/24/1996 |
SORBCEL ALGINATE/CMC WOUND DRESSING |
INNOVATIVE TECHNOLOGIES LTD. |
PRISCILLA WHITEHEAD |
| K962199 |
06/07/1996 |
QUANTEX C3 |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K962198 |
06/07/1996 |
QUANTEX C4 |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K962200 |
06/07/1996 |
QUANTEX IGA |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K962202 |
06/07/1996 |
QUANTEX IGG |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K962201 |
06/07/1996 |
QUANTEX IGM |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K962190 |
06/06/1996 |
PATELLOFEMORAL JOINT PROSTHESIS |
INTERMEDICS ORTHOPEDICS |
SAM MIRZA |
| K962289 |
06/14/1996 |
SELECT SHOULDER COCR HUMERAL STEM COMPONENT |
INTERMEDICS ORTHOPEDICS |
MITCHELL A DHORITY |
| K962315 |
06/17/1996 |
SELECT SHOULDER COCR HUMERAL STEM COMPONENT |
INTERMEDICS ORTHOPEDICS |
MITCHELL A DHORITY |
| K962224 |
06/10/1996 |
SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS |
INTERMEDICS ORTHOPEDICS |
MITCHELL A DHORITY |
| K962238 |
06/11/1996 |
SELECT SHOULDER KEELED ALL-POLY GLENOIDS |
INTERMEDICS ORTHOPEDICS |
MITCHELL A DHORITY |
| K962244 |
06/11/1996 |
SELECT SHOULDER PEGGED ALL-POLY GLENOID |
INTERMEDICS ORTHOPEDICS |
MITCHEL A DHORITY |
| K962174 |
06/05/1996 |
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) |
INTERMEDICS, INC. |
LORI KLEINSCHRODT HOLDER |
| K962456 |
06/25/1996 |
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K962279 |
06/13/1996 |
ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES |
JANE FUI OPTICAL CO., LTD. |
JAMES WU |
| K962235 |
06/11/1996 |
VITROS SPECIALTY DILUENT |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
BRADFORD M SPRING |
| K962226 |
06/10/1996 |
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM |
JOHNSON & JOHNSON MEDICAL, INC. |
PHYLLIS ELSON |
| K962248 |
06/11/1996 |
P.F.C. CERAMIC HIP HEAD |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
ANNE M GRIFFIN |
| K962429 |
06/24/1996 |
SAFETY VEST |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JOHANNA ADLER |
| K962212 |
06/10/1996 |
KARL STORZ FRIMBERGER VARIOGUIDE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARIKA ANDERSON |
| K962396 |
06/21/1996 |
KSEA BIPOLAR GOAGULATING FORCEPS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K962393 |
06/20/1996 |
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K962515 |
06/27/1996 |
KERR ADVANCED ADHESIVE |
KERR DENTAL MATERIALS CENTER |
WILLIAM R PIKE |
| K962528 |
06/27/1996 |
OLYMPUS MOBILE CHAIR/COUCH |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
ROGER GRAY |
| K962225 |
06/10/1996 |
VIEWSEND MEDICAL MODEL 1200 |
KLT TELECOM, INC. |
KEITH E RIEGER |
| K962376 |
06/20/1996 |
KREATIV KURING LIGHT SYSTEM |
KREATIV, INC. |
CHARLES W WHUTCHINS |
| K962361 |
06/19/1996 |
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND |
LAERDAL MEDICAL CORP. |
KENNETH B HERLAND |
| K962236 |
06/11/1996 |
SCARF THREAD-HEAD SCREW |
LANDOS, INC. |
NORMAN F ESTRIN |
| K962233 |
06/11/1996 |
TWIST-OFF SCREW |
LANDOS, INC. |
NORMAN F ESTRIN |
| K962918 |
06/27/1996 |
LIDCO SYSTEM |
LIDCO LTD. |
TOM TSAKERIS |
| K962354 |
06/18/1996 |
DIOMED 15, 30, 60 SURGICAL DIODE LASER |
LIFESTREAM INT'L, INC. |
STEVEN CLARKE |
| K962173 |
06/05/1996 |
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES |
MALLINCKRODT MEDICAL |
MICHAEL B SCHOECK |
| K962273 |
06/13/1996 |
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST |
MARLO SURGICAL TECHNOLOGY |
ARTHUR S GODDARD |
| K962220 |
06/10/1996 |
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER |
MARQUEST MEDICAL PRODUCTS, INC. |
TOM DIELMANN |
| K962223 |
06/10/1996 |
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER |
MARQUEST MEDICAL PRODUCTS, INC. |
TOM DIELMANN |
| K962547 |
06/28/1996 |
CARDIOSERV P |
MARQUETTE ELECTRONICS, INC. |
KRISTIN PABST |
| K962551 |
06/28/1996 |
CARDIOSERV S |
MARQUETTE ELECTRONICS, INC. |
KRISTIN PABST |
| K962513 |
06/27/1996 |
DERMAPLEX HYDROGEL WOUND DRESSING |
MAXXIM MEDICAL |
RICHARD A HAMER |
| K962342 |
06/18/1996 |
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
SUSAN EICHLER-HUSTON |
| K962433 |
06/24/1996 |
MEADOX EXXCEL EPTFE VASCULAR GRAFT |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
STEPHEN B ANDERSON |
| K962527 |
06/27/1996 |
GENERAL PURPOSE DENTAL TRAY |
MEDCARE MEDICAL GROUP, INC. |
CRAIG J BELL |
| K962328 |
06/06/1996 |
SINGLE USE INSTRUMENT TRAY |
MEDCARE MEDICAL GROUP, INC. |
CRAIG J BELL |
| K962147 |
06/03/1996 |
DEXTERITY PNEUMO SLEEVE SET |
MEDICAL CREATIVE TECHNOLOGIES, INC. |
PERK CROOK |
| K962489 |
06/26/1996 |
CHROMOLIZE TPA ASSAY KIT |
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
MICHAEL D BICK |
| K962194 |
06/07/1996 |
MLI SOFT TISSUE SCREW & WASHER SYSTEM |
MEDICINE LODGE, INC. |
BRIAN T CLEARY |
| K962205 |
06/07/1996 |
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K962129 |
06/03/1996 |
CONTINUOUS FLUSH DEVICE |
MERIT MEDICAL SYSTEMS, INC. |
DENNIS REIGLE |
| K962520 |
06/27/1996 |
DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A |
MESURE TECHNOLOGY |
PHIL Z ULUETA |
| K962237 |
06/11/1996 |
THUMPER CARDIOPULMONARY RESUSCITATOR |
MICHIGAN INSTRUMENTS, INC. |
JAMES D MAATMAN |
| K962483 |
06/26/1996 |
MIDAS REX III MOTOR |
MIDAS REX PNEUMATIC TOOLS, INC. |
MICHAEL FOWLER |
| K962298 |
06/13/1996 |
CENTER OPTICAL GLASSES |
MIRAGE EYEWEAR, INC. |
FU-LIN HU |
| K962163 |
06/04/1996 |
MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL |
MISTEN MEDICAL CORP. |
GEORGE W MURRAY |
| K962511 |
06/27/1996 |
MITEK MICRO ANCHOR |
MITEK PRODUCTS |
EDWARD F KENT |
| K962525 |
06/27/1996 |
ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM |
MORWEL CORP. |
BRENDA HUNT |
| K962160 |
06/04/1996 |
MPM HYDROGEL DRESSING (NON-STERILE) |
MPM MEDICAL, INC. |
RICHARD A HAMER |
| K962254 |
06/12/1996 |
NHMC URETHRAL CATHETERIZATION TRAY |
NATIONAL HEALTHCARE MFG. CORP. |
BOB JACKSON |
| K962379 |
06/20/1996 |
SEAGER ELECTROEJACULATOR |
NATIONAL REHAB HOSPITAL |
S.W.J. SEAGER |
| K962516 |
06/27/1996 |
TAP ANTI-SNORING DEVICE |
NELLCOR PURITAN BENNETT, INC. |
CHRIS HADLAND |
| K962319 |
06/17/1996 |
NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES |
NEOPROBE CORP. |
SUSAN TIEDY-STEVENSON |
| K962227 |
06/10/1996 |
PRO-FECT STERILE GAUZE SPONGES |
NETWORK TRADING CORP. DBA GRAND INTL. |
DERICK LI |
| K962208 |
06/10/1996 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
| K962408 |
06/21/1996 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
| K962492 |
06/26/1996 |
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
NIDEK MEDICAL PRODUCTS, INC. |
GREGG GASKINS |
| K962169 |
06/05/1996 |
MAGNETO EYEWEAR |
NIKE, INC. |
ANDREW P MOONEY |
| K962412 |
06/21/1996 |
NIKE V8 AND NIKE V12 |
NIKE, INC. |
JOHN B DUBECK |
| K962130 |
06/03/1996 |
BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE |
NOBELPHARMA USA, INC. |
MARY EDWARDS |
| K962403 |
06/21/1996 |
NOBLEPHARMA WIDE ACCESSORIES |
NOBELPHARMA USA, INC. |
MARY EDWARDS |
| K962352 |
06/18/1996 |
HYDROGEL SKIN DRESSING |
NORTH AMERICAN STERILIZATION & PACKAGING CO. |
CHARLES E MEISCH |
| K962271 |
06/13/1996 |
ELECTROSURGICAL ELECRTRODES |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K962542 |
06/28/1996 |
AIR MOTOR HANDPIECE TN-102 |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K962543 |
06/28/1996 |
ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K962540 |
06/28/1996 |
E-TYPE CONTRA ANGLE NAC-E |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K962127 |
06/03/1996 |
OHMEDA 3800 PULSE OXIMETER |
OHMEDA MEDICAL |
CHARLES MORREALE |
| K962367 |
06/19/1996 |
OLYMPUS BASKET GRASPERS |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K962380 |
06/20/1996 |
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K962409 |
06/21/1996 |
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K962485 |
06/26/1996 |
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K962474 |
06/25/1996 |
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K962378 |
06/20/1996 |
OLYMPUS FG-45/46-1 GRASPING FORCEPS |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K962387 |
06/20/1996 |
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K962533 |
06/28/1996 |
OLYPUS FG SERIES GRASPING FORCEPS |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K962435 |
06/24/1996 |
STC AUTO-LYTE URINARY GLUCOSE ASSAY |
ORASURE TECHNOLOGIES, INC. |
LISA VAIL |
| K962448 |
06/24/1996 |
PRIMALOC CEMENTED HIP SYSTEM |
ORTHO DEVELOPMENT CORP. |
MICHELLE M PERRY |
| K962314 |
06/17/1996 |
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM |
OSTEONICS CORP. |
CHARLES RYAN |
| K962152 |
06/04/1996 |
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM |
OSTEONICS CORP. |
DONNA S WILSON |
| K962132 |
06/03/1996 |
SILKON STAINLESS STEEL CABLE SYSTEM |
OSTEONICS CORP. |
CHARLES RYAN |
| K962228 |
06/10/1996 |
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT |
OTOTECH INTL., INC. |
DAVID A HOUGH |
| K962522 |
06/14/1996 |
MODEL SL-YZ5E |
PACIFIC OPHTHALMIC SUPPLY |
WILL MARKLE |
| K962176 |
06/05/1996 |
TPP |
PANBIO, INC. |
CHRISTOPHER NOTESTINE |
| K962534 |
06/28/1996 |
THERA-MIST NEBULIZER MODEL-P3000 |
PEGASUS RESEARCH CORP. |
MICHAEL HENNIGMAN |
| K962460 |
06/25/1996 |
EG-3800T, VIDEO GASTROSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| K962219 |
06/10/1996 |
QUICKSTICK ONE STEP PREGNANCY TEST(9010) |
PHAMATECH |
TUAN PHAM |
| K962274 |
06/13/1996 |
UNICAP 100 |
PHARMACIA, INC. |
KAREN E MATIS |
| K962144 |
06/03/1996 |
PHOENIX ETE TISSUE EXTENSION SYSTEM |
PHOENIX BIOMEDICAL CORP. |
HORACE J WILMER |
| K962359 |
06/19/1996 |
LIFEPAK 300 |
PHYSIO-CONTROL CORP. |
SHERRI L POCOCK |
| K962447 |
06/24/1996 |
EQUINOX DIGITAL EEG SYSTEM |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K962157 |
06/04/1996 |
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K962288 |
06/14/1996 |
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER |
PINNACLE PRODUCTS, INC. |
THOMAS LASING |
| K962374 |
06/20/1996 |
FIBER-SPLINT ML MULTILAYER |
POLYDENTIA USA |
ROBERT W BAUER |
| K962512 |
06/27/1996 |
BOSTON CONTACT LENS CASE |
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. |
DEBRA L.B. KETCHUM |
| K962287 |
06/14/1996 |
EAGLE EYES SUNGLASSES |
POSITIVE RESPONSE TELEVISION |
JAY H GELLER |
| K962353 |
06/18/1996 |
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG, PH.D. |
| K962182 |
06/06/1996 |
BURLEW INFANT HOOD |
PROMEDIC, INC. |
PAUL E DRYDEN |
| K962518 |
06/27/1996 |
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES |
PT. IRAMA DINAMIKA LATEX |
ANIL TANEJA |
| K962383 |
06/20/1996 |
PULPDENT RESILUTE II |
PULPDENT CORP. |
KENNETH J BERK |
| K962399 |
06/21/1996 |
HEPATITIS NEGATIVE CONTROL |
PYRAMID BIOLOGICAL CORP. |
JEANETTE R PORRETTA |
| K962425 |
06/24/1996 |
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) |
RADI MEDICAL SYSTEMS AB |
PER EGNELOV |
| K962334 |
06/17/1996 |
EML105 ELECTROLYTE METABOLITE ANALYZER |
RADIOMETER AMERICA, INC. |
DONALD L BAKER |
| K962158 |
06/04/1996 |
PICO MODELS 30, 50, 70 |
RADIOMETER AMERICA, INC. |
DONALD L BAKER |
| K962155 |
06/04/1996 |
GILL-THOMAS-COSMAN(GTC) DENTAL TRAY |
RADIONICS SOFTWARE APPLICATIONS, INC. |
AMY LAFORTE, PH.D. |
| K962313 |
06/17/1996 |
MODIFIED LEVEEN NEEDLE ELECTRODE |
RADIOTHERAPEUTICS CORP. |
COLIN J NICHOLS |
| K962386 |
06/20/1996 |
SENSOR SHEATH TS1 |
RADIOTHERAPEUTICS CORP. |
COLIN J NICHOLS |
| K962441 |
06/24/1996 |
PROSPORE(STEARO FOR STEAM STERILIZER) |
RAVEN BIOLOGICAL LABORATORIES, INC. |
KERRIE GROFF |
| K962203 |
06/07/1996 |
WHISPER SWIVEL II EXHALATION PORT |
RESPIRONICS, INC. |
FRANCIS X DOBSCHA |
| K962439 |
06/24/1996 |
DERMAPLEX HYDROGEL WOUND DRESSING (2"X2",4"X4",4"X8",6"X10") |
RICHARD HAMER ASSOC., INC. |
RICHARD A HAMER |
| K962172 |
06/05/1996 |
FLEXIBLE MINI-FIBERSCOPES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT CASARSA |
| K962280 |
06/13/1996 |
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K962231 |
06/10/1996 |
COBAS CORE IMMUNOCHEMISTRY SYSTEM |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K962165 |
06/04/1996 |
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K962411 |
06/21/1996 |
ONTRAK TESTCUP AMPHETAMINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K962472 |
06/25/1996 |
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER |
RUSCH INTL. |
NEIL R ARMSTRONG |
| K962151 |
06/04/1996 |
RYDER LACRIMAL INTUBATIONSET |
RYDER INTL. CORP. |
DAN CLARK |
| K962487 |
06/26/1996 |
BREAST TREATMENT AID M200 |
S. AND H. ENGINEERING, INC. |
SYDNEY GOLDSTEIN |
| K962139 |
06/03/1996 |
SAFESKIN |
SAFESKIN CORP. |
MICHELLE MOLLOY |
| K962168 |
06/05/1996 |
MUCUS SPECIMEN TRAP |
SAGE PRODUCTS, INC. |
KAREN PINTO |
| K962464 |
06/25/1996 |
SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) |
SCANTIBODIES LABORATORY, INC. |
RICHARD LENART |
| K962179 |
06/06/1996 |
STAT IM 5000 CASSETTE AUTOCLAVE |
SCICAN |
NEIL MCPHAIL |
| K962360 |
06/19/1996 |
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES |
SCIMEDX CORP. |
GARY LEHNUS |
| K962327 |
06/17/1996 |
SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE |
SEKURE SEAT CORP. |
LAURA ANN REID |
| K962446 |
06/24/1996 |
SHARPLAN RUBY LASER SYSTEM |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
| K962461 |
06/25/1996 |
NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K962133 |
06/03/1996 |
EXPANDACELL INJECTO-PAK |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
SARAH M LAKE |
| K962170 |
06/05/1996 |
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP |
SIEMENS HEARING INSTRUMENTS, INC. |
GARY W ROESEL |
| K962404 |
06/21/1996 |
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ROBERT W BECKER |
| K962291 |
06/14/1996 |
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JACQUELINE EMERY |
| K962142 |
06/03/1996 |
SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE HESLER |
| K962413 |
06/21/1996 |
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER |
SIERRA LABORATORIES, INC. |
ANNA PEREZ |
| K962384 |
06/20/1996 |
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER |
SIERRA LABORATORIES, INC. |
ANNA PEREZ |
| K962239 |
06/11/1996 |
SMART ADJUSTER (SA201) |
SIGMA |
TAMAS BECSE |
| K962377 |
06/20/1996 |
3D-SPINE |
SKILL TECHNOLOGIES, INC. |
|
| K962137 |
06/03/1996 |
GENESIS II CONSTRAINED SYSTEM |
SMITH & NEPHEW RICHARDS, INC. |
THOMAS L CRAIG |
| K962541 |
06/28/1996 |
REFLECTION ACETABULAR REINFORCEMENT RINGS |
SMITH & NEPHEW RICHARDS, INC. |
THOMAS L GRAIG |
| K962462 |
06/25/1996 |
MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR |
SMITH AND NEPHEW DONJOY, INC. |
DAN W MILLER |
| K962175 |
06/05/1996 |
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
TIMOTHY J TALCOTT |
| K962149 |
06/04/1996 |
SAFETY CRADLE |
SPECIALIZED HEALTH PRODUCTS, INC. |
WILLIAM E MCKAY |
| K962418 |
06/24/1996 |
UREA NITROGEN (BUN) LIQUI-UV |
STANBIO LABORATORY |
KIRK JOHNSON |
| K962449 |
06/24/1996 |
OSTEO COMPACTION KIT |
STERI-OSS, INC. |
DON KENNARD |
| K962545 |
06/28/1996 |
DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE |
STERILIZATION CASSETTE SYSTEMS, INC. |
STEPHEN F SPENCER |
| K962302 |
06/17/1996 |
PEGASUS DENTAL ALLOY |
STERNGOLD/IMPLAMED |
NICHOLAS J SAVARESE |
| K962325 |
06/17/1996 |
QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) |
STERNGOLD/IMPLAMED |
NICHOLAS J SAVARESE |
| K962304 |
06/17/1996 |
STERNGOLD BIO-4 |
STERNGOLD/IMPLAMED |
NICHOLAS J SAVARESE |
| K962326 |
06/17/1996 |
STERNGOLD BIO-5 (1127210) |
STERNGOLD/IMPLAMED |
NICHOLAS J SAVARESE |
| K962303 |
06/17/1996 |
STERNGOLD CF |
STERNGOLD/IMPLAMED |
NICHOLAS J SAVARESE |
| K962324 |
06/17/1996 |
STERNGOLD U-CPF METAL ALLOY (1067800) |
STERNGOLD/IMPLAMED |
NICHOLAS J SAVARESE |
| K962320 |
06/17/1996 |
S3 CARDIOPLEGIA CONTROL |
STOECKERT INSTRUMENTE |
DIANE MINEAR |
| K962131 |
06/03/1996 |
STORZ D4600 AIR EXCHANGE LINE PACK |
STORZ INSTRUMENT CO. |
AUDREY SWEARINGEN |
| K962252 |
06/12/1996 |
HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 |
SUNBEAM HEALTH DIVISION |
FRANK BRICHETTOR |
| K962195 |
06/07/1996 |
HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 |
SUNBEAM HEALTH DIVISION |
FRANK BRICHETTO |
| K962192 |
06/07/1996 |
SUNRISE CURING LAMP |
SUNRISE TECHNOLOGIES, INC. |
CAROL KIM |
| K962193 |
06/07/1996 |
PORTLAND TROCARS |
SURGICAL INNOVATIONS PLC |
MICHAEL A CLARK |
| K962443 |
06/24/1996 |
N95 FILTERING FACEPIECE |
SURVIVAIR, INC. |
GRACE HOLLAND |
| K962479 |
06/26/1996 |
SYNERMED ISE REAGENTS |
SYNERMED, INC. |
MARCIA J ARENTZ |
| K962272 |
06/13/1996 |
SYNTHES MANDIBLE DISTRACTOR |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K962484 |
06/26/1996 |
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K962476 |
06/25/1996 |
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR |
TAMBRANDS, INC. |
JEROME B WAINICK |
| K962503 |
06/27/1996 |
GUGLIELMI DETACHABLE COIL |
TARGET THERAPEUTICS |
LARAINE PANGELINA |
| K962283 |
06/13/1996 |
EEG ELECTRODES |
TECA, INC. |
WILLIAM H BROWN |
| K962278 |
06/13/1996 |
SUPERSTAND STAND-UP WHELLCHAIR |
THE STANDING CO., INC. |
DAVID MACZIK |
| K962301 |
06/17/1996 |
STERNGOLD G-HARD METAL ALLOY |
THE STERN METALS CO., INC. |
NICHOLAS J SAVARESE |
| K962259 |
06/12/1996 |
"LIBBE RECTAL TUBE" (FORMERLY A YANKAUER SUCTION TUBE) |
TILLER MIND BODY, INC. |
JERI TILLER |
| K962496 |
06/26/1996 |
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) |
TISSUE TECHNOLOGIES, INC. |
JESSE KRAMER, PH.D. |
| K962138 |
06/03/1996 |
FLEXART V3.1 SOFTWARE |
TOSHIBA AMERICA MRI, INC. |
JAVAD SEYEDZADEH |
| K962475 |
06/25/1996 |
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM |
TRANSFUSION TECHNOLOGIES CORP. |
JOHN J SOKOLOWSKI |
| K962481 |
06/26/1996 |
QUASAR RECOVERY IMAGING PACKAGE |
TRIONIX RESEARCH LABORATORY, INC. |
CHUN B LIM, PH.D. |
| K962337 |
06/17/1996 |
ELITYS OR ELITYS-E |
TROPHY RADIOLOGIE |
MARIE PIERRE LABAT-CAMY |
| K962282 |
06/12/1996 |
TUTTNAUER PREVACUUM TABLE AUTOCLAVE |
TUTTNAUER USA CO. LTD. |
ROBERT R BASILE |
| K962494 |
06/26/1996 |
PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE |
U.S. BIOMATERIALS CORP. |
DAPHNA R ARIEL |
| K962215 |
06/10/1996 |
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER |
U.S. MEDICAL PRODUCTS, INC. |
MARY ELLEN FREDDO |
| K962369 |
06/19/1996 |
TALKING DIGITAL THERMOMETER |
ULTMOST INDUSTRIAL CORP. |
HOWARD M HOLSTEIN |
| K962332 |
06/17/1996 |
TENS/FES/NMES ELECTRODES |
UNI-PATCH, INC. |
THOMAS MOORE |
| K962336 |
06/17/1996 |
RADIOGRAPHIC FILM CASSETTES |
UNIDEX GROUP, INC. |
HENRY LEE |
| K962338 |
06/17/1996 |
RADIOGRAPHIC GRID |
UNIDEX GROUP, INC. |
HENRY LEE |
| K962296 |
06/12/1996 |
STREPTOLEX-STAT |
UNIPATH LTD. |
FRAN WHITE |
| K962388 |
06/20/1996 |
"IN THE EAR" HEARING AID |
UNIQUE HEARING TECHNOLOGY, INC. |
LARRY LERITZ |
| K962211 |
06/10/1996 |
UBI MAGIWEL THYROXINE (T4) QUANTITATIVE |
UNITED BIOTECH, INC. |
WUAN T LU |
| K962346 |
06/18/1996 |
PAPILLOTOME |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN YOUNKER |
| K962180 |
06/06/1996 |
CATH SEAL |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
RICHARD LINKERT |
| K962153 |
06/04/1996 |
DIGITAL IMAGE ANALYSIS SYSTEM |
UNIVERSITY OF WASHINGTON |
FLORENCE H SHEEHAN, M.D. |
| K962389 |
06/20/1996 |
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE |
UNOMEDICAL SDN BHD |
PATRICK J LAMB |
| K962148 |
06/03/1996 |
VERGE VIDEOMETER |
VERG, INC. |
VERNON C TAYLOR |
| K962333 |
06/17/1996 |
V.R.S. DENTURE RESIN MATERIAL |
VIDENT |
RAY E MORROW |
| K962438 |
06/24/1996 |
MISTY OX TURBOHEATER |
VITAL SIGNS, INC. |
DOUGLAS R MONGEON |
| K962241 |
06/11/1996 |
GORE SPHEREX IMPLANT |
W.L. GORE & ASSOCIATES,INC |
JOHN W NICHOLSON |
| K962401 |
06/21/1996 |
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES |
W.L. GORE & ASSOCIATES,INC |
R. LARRY PRATT |
| K962188 |
06/06/1996 |
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) |
WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
CHOW YUE WAH |
| K962189 |
06/06/1996 |
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) |
WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
CHOW YUE WAH |
| K962251 |
06/12/1996 |
MEDOFF SLIDING PLATE (PROPOSED NAME) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JUDY ENGLISH |
| K962267 |
06/13/1996 |
PERFECTA PS REVISION STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CRISITIE MANUEL |
| K962382 |
06/20/1996 |
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. |
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. |
SUN-MOU LEE |
| K962196 |
06/06/1996 |
NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS |
ZIMMER, INC. |
RUTH ANN WOOD |
| K962397 |
06/21/1996 |
STATAK SOFT TISSUE ATTACHMENT DEVICE |
ZIMMER, INC. |
LYNNETTE WHITAKER |
